Functional DyspepsiaPhase 4NCT04647955
Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup
A Phase 4 study testing Itopride in people with Functional Dyspepsia and Postprandial Fullness Syndrome, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Dyspepsia, Postprandial Fullness Syndrome
- What is being tested?
- Itopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2013to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see appendix 1B)
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 18 and 70 years inclusive
- Male or female patients
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements
Who cannot join
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). Patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline) during the last 3 months are eligible.
- Females who are pregnant or lactating.
- Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months.
- Patients suffering from diabetes type 1 or type 2.
- Patients taking medication for functional dyspepsia will need a wash-out period of 2 weeks before they can be screened
Show all 16Show fewer
- Patients with known hypersensitivity to gastroprokinetic drugs.
- Patients with confirmed gastro-intestinal disease.
- Patients with former digestive surgery affecting upper gut motility.
- Patients affected by concomitant disease responsible for digestive symptoms
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
- Patients presenting symptoms of EPS several times a week according to Rome III questionnaire
- Patients presenting daily symptoms of CIN on Rome III questionnaire
- Patients presenting vomiting more than one day a month.
- Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire
- Patients presenting predominant GERD according to GERD questionnaire
About this study
Official title: Validation of a Questionnaire for Symptom Assessment in Postprandial Distress Syndrome (Functional Dyspepsia)
Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. At present, no validated instrument is available for the assessment of the symptom responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have previously conducted focus group sessions and cognitive interviews in PDS patients to identify all relevant symptom items that characterize PDS. In this study we aim to validate the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its consistency, reliability and ability to detect change in the framework of a controlled treatment trial.
- Being tested
- Itopride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItoprideDrug
Itopride is a D2 antagonist and cholinesterase inhibitor with prokinetic effects on gastric motility used to treat functional dyspepsia. Patients were treated for 8 weeks.
PlaceboDrug
Patients were treated for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Itopride | Experimental | Oral dose of itopride 100 mg three times daily before the meal for 8 weeks Receives: Drug: Itopride |
| Placebo | Placebo comparator | Oral dose of placebo three times daily before the meal for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of LPDS questionnaire
Responsiveness of LPDS
Measured: 8 weeks
Secondary outcomes (3)
Percentage of subject that improved after treatment with itopride based on the LPDS validated questionnaire
Percentage of subjects that show a decrease of at least 0.5 in the LPDS score at the end of the treatment. We calculated the number of patients that reached the LPDS MCID (≥0.5) and at a higher response threshold (≥0.7) and differences between proportions were analysed with the Chi-squared test.
Measured: 8 weeks
Efficacy of itopride compared to baseline based on the LPDS validated questionnaire
Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
Measured: 8 weeks
Efficacy of itopride compared to baseline in the dyspepsia subgroups on based on the LPDS validated questionnaire
Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start22 Feb 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647955
- Sponsor's protocol ID
- LPDSItopride
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carbone F, Vandenberghe A, Holvoet L, Piessevaux H, Arts J, Caenepeel P, Staessen D, Vergauwe P, Maldague P, De Ronde T, Wuestenberghs F, Lamy V, Lefebvre V, Latour P, Vanuytsel T, Jones M, Tack J. A double-blind randomized, multicenter, placebo-controlled study of itopride in functional dyspepsia postprandial distress syndrome. Neurogastroenterol Motil. 2022 Aug;34(8):e14337. doi: 10.1111/nmo.14337. Epub 2022 Mar 31.
PubMed 35357058
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Questionnaire for Symptom Assessment in Postprandial Distress Syndrome (Functional Dyspepsia)
- ClinicalTrials.gov ID
- NCT04647955
- Acronym / sponsor ID
- LPDSItopride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. At present, no validated instrument is available for the assessment of the symptom responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have previously conducted focus group sessions and cognitive interviews in PDS patients to identify all relevant symptom items that characterize PDS. In this study we aim to validate the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its consistency, reliability and ability to detect change in the framework of a controlled treatment trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itopride | Experimental | Drug: ItoprideOral dose of itopride 100 mg three times daily before the meal for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral dose of placebo three times daily before the meal for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire (see appendix 1B)
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 18 and 70 years inclusive
- Male or female patients
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements
Key exclusion criteria (16 listed)
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with an active major psychiatric condition (depression, anxiety disorder, alcohol or substance abuse). Patients who are taking a stable dose of a single antidepressant (with the exception of amitryptiline) during the last 3 months are eligible.
- Females who are pregnant or lactating.
- Patients who are H. Pylori positive or patients who received treatment for HP eradication during the last 3 months.
- Patients suffering from diabetes type 1 or type 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ItoprideItopride is a D2 antagonist and cholinesterase inhibitor with prokinetic effects on gastric motility used to treat functional dyspepsia. Patients were treated for 8 weeks. | Drug | Itopride |
| PlaceboPatients were treated for 8 weeks. | Drug | Placebo |
Primary outcome
Validation of LPDS questionnaire
Time frame: 8 weeks
Responsiveness of LPDS
3 secondary outcomes
Percentage of subject that improved after treatment with itopride based on the LPDS validated questionnaire
Time frame: 8 weeks
Efficacy of itopride compared to baseline based on the LPDS validated questionnaire
Time frame: 8 weeks
Efficacy of itopride compared to baseline in the dyspepsia subgroups on based on the LPDS validated questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Derived from this study: PubMed 35357058Carbone F, Vandenberghe A, Holvoet L, Piessevaux H, Arts J, Caenepeel P, Staessen D, Vergauwe P, Maldague P, De Ronde T, Wuestenberghs F, Lamy V, Lefebvre V, Latour P, Vanuytsel T, Jones M, Tack J. A double-blind randomized, multicenter, placebo-controlled study of itopride in functional dyspepsia postprandial distress syndrome. Neurogastroenterol Motil. 2022 Aug;34(8):e14337. doi: 10.1111/nmo.14337. Epub 2022 Mar 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Itopride in people with Functional Dyspepsia and Postprandial Fullness Syndrome, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of LPDS questionnaire (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.